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CERVIDIL SUMMARY

CERVIDIL®Brand of dinoprostone vaginal insert

Dinoprostone vaginal insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system. Each slab is buff colored, semitransparent and contains 10 mg of dinoprostone in a hydrogel insert. An integral part of the knitted polyester retrieval system is a long tape designed to aid retrieval at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.

Cervidil Vaginal Insert (dinoprostone, 10 mg) is indicated for the initiation and/or continuation of cervical ripening in patients at or near term in whom there is a medical or obstetrical indication for the induction of labor.

Feasibility of monitoring with Monica AN 24 both in hospital and at home will be confirmed
in a pilot study. The success will be defined as at least 10 minutes of continuous
satisfactory trace in any given hour in at least 80% of the patient.

A main study will then be conducted to assess the feasibility and acceptability of the PRAM
(Propess and Monica) package of care for women undergoing induction of labour.

Reduced Intensity, Sequential Double Umbilical Cord Blood Transplantation Using Prostaglandin E2 (PGE2) [Recruiting]
The purpose of this research study is to determine the effects of 16, 16
Dimethyl-Prostaglandin E2 (dmPGE2) treatment on umbilical cord blood units to be used in
transplantation. dmPGE2 treatment is being tested to see if it can improve the ability of
umbilical cord blood stem cells to grow after transplantation. The growth of stem cells
after transplantation is sometimes referred to as "engraftment". One of the major problems
after umbilical cord transplantation is the time required for engraftment. After
transplantation of two umbilical cord blood units, the average time to achieve engraftment
is 21 days. In addition, up to 10% of patients who undergo umbilical cord blood
transplantation never engraft, a potentially life-threatening condition. In laboratory
studies, treatment of umbilical cord blood stem cells with dmPGE2 was shown to enhance
engraftment.

The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery
rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed
induction in the United States is rising. This has led to a renewed effort to examine the
effectiveness of the varied methods of induction.

The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel
for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto
Health Richland for a scheduled induction of labor will be offered enrollment in the trial.
Patients who enroll in the study will be randomized into one of 3 study arms: urinary
balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and
prostaglandin gel. Randomization will be per sealed envelope from the locked nurse
medication storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland.
The investigator will be given the next sequentially numbered study randomization envelope
by the patient's nurse. The randomization assignment will be unblinded to the patient and
her physicians. If the patient is not in active labor 6 hours after initiation of the
intervention, a standardized protocol of oxytocin will commence. Labor management will be at
the discretion of the physician.